Albuquerque, N.M.—Two groups of investigators successfully withdrew corticosteroids from different patient populations, according to studies presented at the 2013 annual meeting of the American College of Clinical Pharmacy. The first study evaluated long-term effects of steroid withdrawal following kidney transplantation, and the other looked at the efficacy of certolizumab pegol (Cimzia, UCB Pharma) as a steroid-sparing agent in patients with Crohn’s disease.
“Steroids are inexpensive, and they’re effective for quick disease management,” said Eric M. Tichy, PharmD, BCPS, FCCP, a senior clinical pharmacy specialist at Yale-New Haven Hospital, New Haven, Conn., who was not involved in either study. Nevertheless, he said, “Steroids cause a myriad of side effects, including cardiovascular disease and diabetes,” so pharmacists “should help make sure that patients are on the lowest effective dose” or are tapered off completely, if possible.
In the kidney transplant study (abstract 182), Kimi Ueda, PharmD, BCPS, and colleagues analyzed prospective data from the four-year MORE (Mycophenolic Acid Observational REnal Transplant) study. They identified 363 patients who underwent corticosteroid withdrawal by month 3 post-transplant, and compared them with 509 patients who continued to receive corticosteroids. At four years’ post-transplant, biopsy-proven acute rejection and patient survival were similar, but graft survival was higher among those who stopped steroid therapy than among those who continued it (96.9% vs. 93.7%; P=0.03). Adverse events (mainly leukopenia and neutropenia) were higher in the corticosteroid-withdrawal group (64.2% vs. 34.2%; P<0.01).
A Real-World Study
Dr. Ueda, a transplant pharmacist at California Pacific Medical Center, in San Francisco, said this study is important for several reasons. “It is a multicenter, observational [trial] where patients are treated according to clinical practice rather than a specific research protocol. It’s also large—more than 800 patients—and prospective. From the data gathered, we can get an idea of what’s really going on.”
Dr. Ueda said they found “no difference in long-term complications such as osteoporosis, cardiovascular disease risk and new-onset diabetes after transplantation,” but Dr. Tichy said that perhaps the four-year study period was “not enough time to see a difference.”
The other study (abstract 238) analyzed data from the 26-week, randomized controlled PRECiSE 2 (Pegylated Antibody Fragment Evaluation in Crohn’s Disease: Safety and Efficacy 2) trial (N Engl J Med 2007;357:239-250). In this trial, 668 adults with active Crohn’s disease who responded to an open-label loading dose of certolizumab pegol were given continuous therapy with certolizumab pegol, at a dosage of 400 mg, or placebo every four weeks for 24 weeks. Among the patients taking corticosteroids at baseline who responded to the loading dose of certolizumab pegol, 45 began a corticosteroid taper with certolizumab pegol therapy. Of these, 31% (14 of 45) were in corticosteroid-free clinical remission at week 26.
Lead author Tanna Hassig, PharmD, BCPS, a clinical pharmacy specialist at the Medical University of South Carolina, in Charleston, noted the important role of pharmacists in minimizing exposure to corticosteroids. “The hospital pharmacist has to see how long the patient has been on steroids, look at the patient’s entire medication regimen, and understand what is the long-term plan.”
Drs. Hassig and Tichy reported no relevant financial conflicts of interest. Some of Dr. Hassig’s co-authors are employees of UCB Pharma. Dr. Ueda reported being on the speakers’ bureau for Novartis and receiving grant support from Bristol-Myers Squibb. Some of Dr. Ueda’s co-authors are employees of Novartis.